Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

Lymphoma, B Cell Clinical Trial

Official title:

A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210379
• Other study ID #: IELSG10
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: July 21, 2009
• Start date: November 2000
• Est. completion date: March 2007

Study information

• Verified date: July 2009
• Source: International Extranodal Lymphoma Study Group (IELSG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2007
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18 years.

2. ECOG performance status 0-2

3. Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated

4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.

5. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.

6. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)

7. Cardiac ejection fraction = 50% by MUGA scan or echocardiography

8. No previous therapy with monoclonal antibody anti-CD20.

9. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent

10. No other major life-threatening illnesses that may preclude chemotherapy

11. Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice

Exclusion Criteria:

1. impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2 mg/dl) unless due to lymphoma involvement

2. HIV positive patients

3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B Cell
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• rituximab

• CHOP

• intrathecal methotrexate

Procedure:
• radiotherapy

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona

Sponsors (1)

Lead Sponsor	Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival
Primary	Progression-free survival
Primary	Event-free survival
Secondary	Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable

External Links

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